The FDA is looking to shed light on the sometimes murky rules governing compounding operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations.

In April 2016 the agency released three draft guidances addressing multiple facets of the compounding industry including: what constitutes a large-scale compounding facility… associated GMP requirements… standards for hospital compounding… and requirements for compounding without a prescription.

All three guidances emphasize that all products manufactured by outsourcing facilities must comply with GMP rules or be deemed in violation.

If you want to know how these guidances might affect your company, plan on listening to Responding to Compounding Pharmacy Inspections. This 90-minute session will:

Identify the latest areas of FDA enforcement in compounding pharmacies

Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling. With a background in both the law and hands-on healthcare experience (over 10 years as a pharmacist, including participation as a clinician in clinical trials), Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers, including contract manufacturing organizations and contract research organizations.